Specimen sample collection device and test system

ABSTRACT

A specimen sample collection device includes a handle having a sufficiency indicator and an absorbent pad partially contained within said handle. A specimen sample collection device and test system includes a handle having a sufficiency indicator, an absorbent pad partially contained within said handle, a pad compression tube insertable over said absorbent pad within said handle and around an end of said handle, and a collection tube having one or more sample chambers, attachable to said pad compression tube, and wherein said compression tube defines one or more chambers, and wherein when said collection tube is attached to said pad compression tube, the chambers are in fluid communication with said pad compression tube. A specimen sample collection device including a sufficiency indicator made up of a light pipe indicator window. A specimen sample collection device including an absorbent pad split and divided into two lengths connected at a base. A specimen sample collection device including a bar code identification. A specimen sample collection device and test system including a lock and key securing mechanism. A specimen sample collection device including a handle one or more analyte test strips. A specimen sample collection device and test system including a reader.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to prior U.S.Provisional Patent Application Ser. No. 60/539,929 filed on Jan. 28,2004, and 60/630,613 filed on Nov. 23, 2004

FIELD OF THE INVENTION

The present invention relates to devices and methods for the collectionof fluids, and more particularly to devices and methods for thecollection of fluids and methods for testing samples so obtained forfluids including bodily fluids such as saliva.

BACKGROUND

Traditional methods of testing for diseases, drugs and other antigens inhumans have up until the last few years been predominantly done usingblood samples. These samples collected in laboratories at the request ofphysicians require that blood drawn by a trained phlebotomist is sent toa laboratory and the serum component comprising a predominance ofimmunoglobulins, containing antibodies to the disease or disease statein question, is tested using a variety of available test kits to assistin the diagnosis of various diseases including infectious diseases,cardiovascular diseases, cancers and many others. Such samples can alsobe tested for the presence of non-disease analytes such as metals,minerals, DNA, bacteria and organic molecules among others.

Under current standardized laboratory practices, it is necessary toconfirm any initially positive result obtained from diagnostic oranalytical testing with a more sensitive (accurate) method. This, infact is true for most, if not all diagnostic tests used today,including, as an example, HIV tests, which are confirmed by moredefinitive methods such as Western blot techniques or immunofluorescence(IFA) assays. In the case of drug tests, for instance, performed incriminal justice settings (at the police car, in correctionalfacilities, in drug courts, etc.) or at the workplace, by way of twoexamples, confirmation is carried out using gas chromatography-massspectrometry (GC-MS), gas chromatography-massspectrometry-mass-spectrometry (GC-MS-MS) or liquid chromatography-massspectrometry-mass spectrometry (LC-MS-MS) on a second sample taken fromthe subject. Other diagnostic and screening methods require similarlyaccurate methods for confirmatory purposes.

The United States Substance Abuse Mental Health Services Administration(SAMHSA), the designated body responsible for regulating Federal drugtesting in the United States, has recently prepared guidelines for theintroduction of new tests and sample collection procedures for drugtests using so-called, “alternate” specimens. These sample types includesaliva (or oral fluids), hair and sweat. These guidelines define theneed for (1) a confirmatory specimen to be collected at the time of theinitial sampling, (2) defined specimen volumes to be collected and (3)expected drug cut-off values, among other requirements.

The need for duplicate, or a multiplicity of mutually distinct samplestaken from the same source at the same time is part of a general trendbeing observed in many areas of the diagnostic and analytical testingbusinesses. The main reason for this increasingly important trend is thelegal implication of being able to definitively rule out any potentialcontamination of the test sample during the testing process. The obviousconsequences of an incorrect diagnosis of HIV for a patient or erroneousDNA results in the case of a criminal case are just two examples ofwhere 100% certainty of sample integrity are paramount and arecontributing reasons for the development of this particular invention.This potential legal implication has had an impact on general testingprotocols and as a result healthcare and other professionals are nowmore cognizant than ever of the need to collect a “pure” sample orsamples then ensure that those samples are analyzed to produce accurateresults. During the testing process absolute “chain-of-custody” rulesare enforced to ensure that no adulteration or contamination of thespecimen occurs. This is not always possible in current testingprotocols as there are opportunities for sample contamination or sampletampering. This is true for any test whether done on blood, serum,saliva, nasal secretions, vaginal discharge or any other sample whereinformation obtained relates to a diagnosis of disease or disease state.Such information is taken in conjunction with any additional informationavailable to the person making a decision relating to interpretation ofthe results obtained.

Despite the fact that saliva has been used as a diagnostic fluid sinceAncient Chinese times, when the “Rice Test” (which relied on theinhibition of saliva as a determinate of guilt) was used, it is onlyover the last few years that salivary testing has taken on much greatersignificance. There are several important factors, which havecontributed to this change: (1) The increase in popularity of non- orless-invasive testing methods; (2) the availability of more sensitiveantibodies and antigens for detection of immunoglobulins in saliva; (3)new technologies in the area of point-of-care testing; (4) a need formore rapid results; (5) acquisition of serum/blood involves patientdiscomfort and can cause difficulty particularly where young children orintravenous drug users are concerned; (6) use of venous blood to collectserum requires capital equipment and involves an initial processingstep, which adds significant time to result turnaround and hasadditional cost implications and also; (7) a general movement away fromcentralized laboratory testing towards “near-patient” testing, alsocalled “point-of-care” testing.

The National Institutes of Health (NIH) recognized the value of salivarytesting as early as 1993 and recent symposia orchestrated by thisorganization, for instance a meeting held in 1999, organized by NIH'sNational Institute of Dental and Craniofacial Research (NIDCR) divisionhas helped increase the profile of testing using oral fluids. NIH,through various divisions, has since been encouraging companies withexpertise in this area to apply for funding for new projects aimed atintroducing novel tests using non-invasive samples for laboratory andpoint-of-care applications.

The insurance testing industry uses saliva as a sample matrix forapplicants wishing to purchase specific life insurance policies as asafeguard measure prior to writing policies. In these situationsapplicants are tested for HIV, cotinine (nicotine) and cocaine using atesting device called “OraSure” from OraSure Technologies, whichcollects oral fluids for subsequent testing under laboratory conditions.Each of the major insurance testing laboratories in the United Statesperforms a significant number of oral fluid tests on an annual basis.

In April 2004 OraSure Technologies was successful in gaining FDAapproval for its OraQuick® HIV 1/2 rapid test for oral fluid diagnosisof the HIV viruses type 1 and type 2. Previously the test had beenapproved by the agency for whole blood, serum and plasma only.

In a separate area drugs of abuse are routinely detected from oralfluids collected in the workplace, in criminal justice settings and inhospitals using OraSure Technologies' “Intercept™” device and associatedrange of ELISA microplate assays. In this case a panel of 5 “abused”drugs or more are measured under laboratory conditions.

Rapid testing devices using saliva have recently appeared, which may beused at the “point-of-care”. These devices can collect and performimmediate testing for several drugs of abuse but these suffer from poorperformance for certain tests at the present time, particularlyTetrahydrocannabinol (THC) or its major metabolite11-nor-Δ9-Tetrahydrocannabinol. Examples of this type of device are theOraTect™ test from Branan Medical Corporation, the OraLine assay fromSun Biomedical and the Cozart BioScience RapiScan device, among others.

Up until now urine based rapid drug testing has been performedpreferentially due to availability, cost, and to a certain extent, alack of salivary tools incorporating some of the features described inthis invention. While rapid urine kits are widespread they suffer fromissues related to “chain-of-custody”, the need for facilities to collecturine specimens discreetly under appropriate supervision and are easilyadulterated by knowledgeable users, who can “cheat” such tests.

Electronic reading, hand-held devices, such as the Cozart BioSciencesRapiScan instrument are also now available outside of the United States,that allow immediate drug testing to be done from oral fluids at theroadside and other field settings. This technology requires samplecollection from the donor then immediate testing on site. This conceptmay well be duplicated in the future, as technologies to “miniaturize”testing platforms, improves.

The FDA has approved a laboratory HIV test, OraSure HIV-1 for testingfor the HIV-1 virus from oral fluid as well as a Western blotconfirmatory test, which also uses oral fluids. Both have been used in aPublic Health setting in the United States for over five (5) years.

In addition the FDA has also approved saliva tests for pre-term labor(SalEst™, salivary estriol, from Biex, Inc), a salivary alcohol test(QED®, OraSure Technologies), a cortisol assay (Salimetrics, Inc.) aswell as a panel of saliva-based drug assays (Intercept, OraSureTechnologies) through the 510(k) clearance system. A number of otheroral fluid drug testing products are undergoing regulatory approval, soin the next 12-24 months we might expect to see several other productsavailable in the U.S. Furthermore, “investigational use” tests areavailable for immunoglobulins, for example sigA (for use inpsychological disorders, stress and athletic performance), therapeuticdrugs (for instance lithium, theophylline, AZT), tumor markers (e.g.Her-2/neu), bacterial antibodies such as helicobacter pylori and evengenomic detection of mitochondrial DNA (for criminal justiceapplications) using oral fluids as the preferred specimen matrix.

Emerging methodologies based on microfluidic technology requiring onlysmall quantities of specimen samples are approaching the market. Thesedevices work on virtually any specimen matrix including, but not limitedto, saliva, urine, whole blood, serum, and other fluids. Such techniqueshave already found use in the arena of biodefense monitoring, highthroughput screening methods, high performance liquid chromatography(HPLC) and other analytical techniques. These devices, which are beingdeveloped in one particular area for use by special intelligence forces,who are required to test for chemical and biological agents in soil,water and other samples before troops arrive at a battle site or duringpeacekeeping to monitor biological or environmental samples, may be seenas another area where this invention will find application.

These are a few of the many instances where saliva is viewed as a viablesample matrix for testing purposes. A number of devices in use todayhave provided means for the collection of bodily fluids including salivaand urine among others. One FDA-cleared fluid collection device usedpredominantly for saliva collection and testing has been shown to bepotentially unsafe in pediatric patients. The Saliva•Sampler™ devicefrom SDS, Inc. utilizes perforations present on filter paper tofacilitate removal of the filter paper for subsequent saliva separationand testing. The device is placed under the tongue to accumulatesublingual whole saliva, collected by leaving the sampling device,consisting of a filter paper material attached to a plastic stem, inposition until a sample indicator built into the device changes colorconfirming sample sufficiency. The process requires that the subject notchew, bite or unnecessarily move the device during the collectionprocedure. In pediatric patients, particularly, this can be a problem aschildren have a tendency to chew on materials placed in the oral cavity.In infants, separation of the filter paper prematurely can result inchoking.

In another previously described example, an alternate FDA-approved oralfluidcollection system from OraSure Technologies, Inc., known asOraSure®, incorporates salts impregnated on to the collection medium inthe form of a “hypertonic” solution. According to the manufacturers, thepurpose of the salts is to facilitate ready absorption of oral fluids(oral mucosal transudate) from the gingival crevices and thereby reducesampling time. In practice when the OraSure® device is placed in theoral cavity, the taste of the salts on the device medium may bedistasteful to potential users.

These and other currently available devices fail to address a growingneed for efficient collection of bodily fluids including saliva forapplications including analytical or diagnostic testing underlaboratory, field or point-of-care testing conditions, for instance,whereby a pure sample of fluid, for example saliva, is collected from asubject and split into multiple chambers, thereby providing a means forinitial specimen testing analysis or storage, for confirmation orsupplementary testing and simultaneously providing a mechanism forconfirming sample sufficiency prior to any subsequent testing oranalysis of the constituents of the bodily fluid so collected.

Lateral flow immunochromatography (ICT) tests have been around for overa decade and are a direct descendent of thin-layer chromatography (TLC)techniques pioneered during the 1970s. The technology offers somebenefits including cost efficiencies, user-friendliness and theavailability of immediate test results. Over the last decade inparticular, the availability of high quality raw material components,the growing movement towards near patient or point-of-care (“POC”)testing, coupled with a need for rapid results, has led to an“explosion” in the development and commercialization of bothflow-through and lateral flow devices based on immunochromatographictest principles. These devices form part of a rapidly growing industryfor diagnostic tests performed outside of the laboratory.

A variety of ICT tests are now available including as examples OraSureTechnologies' rapid oral fluid test, OraQuick HIV 1/2, QuidelCorporation's Quick-Vue Streptococcus A and Helicobacter pylori rapidtests, Meridian BioSciences' ImmunoCard assays for RespiratorySyncticial Virus (RSV) and Clostridium Difficile (C. Difficile) andRoche Diagnostics' TestCup drugs of abuse tests among a multitude ofothers.

Technologies other than ICT are equally adaptable to rapid testing.These include latex agglutination, dot-blot tests, microarrays andothers.

Of the above rapid test examples and those currently in existence, onlyOraSure Technologies has been successful in commercializing a rapid,oral fluid test, OraQuick HIV 1/2, despite the fact that oral fluid,point-of-care tests represent an attractive alternative to currenttesting methodologies. This may be due, in part, to current datarequirements for approval of rapid tests in the U.S. This is expected tochange as a result of OraSure's success with OraQuick® HIV 1/2 and theemergence of saliva-based drug testing assays.

In order to meet the needs of a growing Public Health demand in the U.S.it is important for would-be manufacturers to integrate test striptechnologies similar to those mentioned above with a simple-to-use,integrated platform system that can deliver rapid test results, safelyand cost-effectively, for a range of diseases or analytes in anon-invasive manner. This is especially important in view of Centers forDisease Control (CDC) estimates that suggest that, of 2.1 million peopletested at Publicly-funded Government testing sites using traditional(laboratory) testing methods in the US for the HIV virus, approximately33% do not return to receive their results and may unwittingly go on toinfect others if they are in fact HIV-positive. As the key to alldisease prevention is early detection, accurate and early detectionusing rapid tests can have a major impact on reducing disease incidence.

In needle-averse populations, for instance, small children, pregnantwomen and hemophiliacs, the opportunity to provide oral fluid or salivacollection and immediate testing as an alternative to blood-basedsystems would be welcomed. Similarly general practitioners and healthprofessionals would see an opportunity to provide testing opportunitiesin non-traditional testing sites, such as in the privacy of thepatient's home, in nursing homes, remote clinic settings and even overthe counter in a pharmacy environment.

Cozart BioSciences (UK, www.Cozart.co.uk)) has described the use of ahand-held device known as RapiScan, which tests for several illicit drugentities from oral fluids. This reading system is not fully integratedand requires a separate collection step prior to testing the specimen.OraSure Technologies (www.OraSure.com) has also described in a recentU.S. patent application (application No. XXXX), the use of a samplecollector and test device. In this example also, sample collection isdistinct from the specimen testing process.

SAMHSA has proposed in its 2004 guidelines for alternate specimentesting that minimum oral fluid collection volumes are to be 2 mL ofclean specimen.

None of the available prior art provides for expressing an oral fluidsample from a subject directly onto a diagnostic test strip, providing amechanism for determining sample volume adequacy and visually readingqualitative and/or quantitative results from the test strip through asmall window in an integrated one-step manner.

The following represents a list of known related art U.S. Pat. No.5,283,038 issued Feb. 1, 1994, U.S. Pat. No. 5,260,031 issued Nov. 9,1993, U.S. Pat. No. 5,268,148 issued Dec. 7, 1993, U.S. Pat. No.5,393,496 issued Feb. 23, 1995, U.S. Pat. No. 5,380,492 issued Jan. 10,1995, U.S. Pat. No. 5,376,337 issued Dec. 27, 1994, U.S. Pat. No.6,267,722, U.S. Pat. No. 6,027,943, U.S. Pat. No. 6,187,598, U.S. Pat.No. 5,965,453, U.S. Pat. No. 5,393,496, U.S. Pat. No. 4,943,522, U.S.Pat. No. 4,895,808, U.S. Pat. No. 6,372,516, U.S. Pat. No. 6,046,058,U.S. Pat. No. 5,962,336, U.S. Pat. No. 5,238,652, U.S. patentapplication Ser. No. 10/061036 by Lloyd Simonson, U.S. patentapplication Ser. No. 10/060605 by Lloyd Simonson, U.S. Pat. No.6,627,152, U.S. Pat. No. 6,727,879, U.S. Pat. No. 5,922,614 to EdwardCesarczyk, U.S. Pat. No. 6,489,172. The teachings of each of theabove-listed citations (which does not itself incorporate essentialmaterial by reference) are herein incorporated by reference. None of theabove inventions and patents, taken either singularly or in combination,is seen to describe the instant invention as claimed.

SUMMARY AND ADVANTAGES

A specimen sample collection device includes a handle having asufficiency indicator and an absorbent pad partially contained withinsaid handle. A specimen sample collection device and test systemincludes a handle having a sufficiency indicator, an absorbent padpartially contained within said handle, a pad compression tubeinsertable over said absorbent pad within said handle and around an endof said handle, and a collection tube having one or more samplechambers, attachable to said pad compression tube, and wherein saidcompression tube defines one or more chambers, and wherein when saidcollection tube is attached to said pad compression tube, the chambersare in fluid communication with said pad compression tube. A specimensample collection device including a sufficiency indicator made up of alight pipe indicator window. A specimen sample collection deviceincluding an absorbent pad split and divided into two lengths connectedat a base. A specimen sample collection device including a bar codeidentification. A specimen sample collection device and test systemincluding a lock and key securing mechanism. A specimen samplecollection device including a handle one or more analyte test strips Aspecimen sample collection device and test system including a reader.

The specimen sample collection device and test system of the presentinvention presents numerous advantages, including: (1) ability tocollect appropriate volumes of specimen sample and confirmation sampleusing a split (fork-shaped) collection medium; (2) ergonomically correctdesign; (3) simple to use; (4) ability to adapt to new testingrequirements; (5) sample containment with minimized chance ofcontamination; (6) utilizes an absorbent pad collection medium ratherthan a filter paper collection medium; (7) provides a unique sampleindicator design that does not utilize a compressible sponge orpolymeric bead; (8) provides a unique sample indicator design that doesnot involve disposing an indicator on filter paper; (9) provides aunique sample indicator design that does not require an adequacyindicator separate from the collection medium; (10) utilizes acollection medium that does not require a rectangular or paddle shape;(11) allows for samples to be removed from individual compartments orchambers and channeled directly or pipetted if necessary, directly intoan alternate receptacle for further analysis or testing; (12) allows forremoval of the specimen directly using high-throughput automatedequipment, which can speed up sampling and analysis tremendously. (13)allows for collection of mutually distinct samples for initial testingor analysis and follow up or supplementary testing either immediately orat a later date; (14) allows for use of “tailored” buffer solutionsdesigned to protect the integrity of various different analytes orsamples collected; (15) utilizes multiple absorbent materials tomaximize the retention and release properties of the invention; (16)allows for testing samples collected immediately using available lateralflow immunochromatographic test strips to deliver test results at thepoint of care; (17) allows for collection of specimen without the needfor an additional filtration or centrifugation step; (18) requires noexpensive capital equipment to collect and process the sample; (19)allows for individual sample identification; (20) allows for a varietyof sample collection tubes to be attached to the end of the inventiondepending upon sample volume requirements and whether single or dualsampling is required; (21) requires minimum manipulation of fluidspecimen; (22) minimizes the chance for contamination of the samplecollected; (23) minimizes the chance of tampering with the samplecollected; (24) provides the ability to rule out contamination; (25)reduces the opportunity for misdiagnosis; (26) provides the ability towork within “chain-of-custody” protocols; (27) provides the ability to arapid test result and a confirmatory result; (28) utilizes an intact padmaterial and does not require that the absorbent pad material beseparated from the main sampling device, so there is a significantlyreduced chance of the pad separating in the subject's mouth when used innormal practice; (29) does not require the use of any salts or hypotonicsolutions impregnated in the collection medium to improve collectiontime; (30) ability to deliver fluids to two test strips or two separatereceiving ports at the same time.

Additional advantages of the invention will be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Theadvantages of the invention may be realized and attained by means of theinstrumentalities and combinations particularly pointed out in theappended claims. Further benefits and advantages of the embodiments ofthe invention will become apparent from consideration of the followingdetailed description given with reference to the accompanying drawings,which specify and show preferred embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of a specimen sample collection device andtest system.

FIG. 2 shows a light pipe indicator window over a dry absorbent pad.

FIG. 3 shows a light pipe indicator window over a saturated absorbentpad

FIG. 4 shows another view of a specimen sample collection device.

FIGS. 5 a, 5 b, and 5 c show different views of a pad compression tube.

FIG. 5 c shows the view of FIG. 5 a from the side.

FIGS. 6 a, 6 b, and 6 c show different views of a chambered collectiontube.

FIG. 6 b shows the view of FIG. 6 a from the side.

FIG. 7 shows a schematic view of aspecimen sample collection device andtest system with a pad compression tube attached to a handle.

FIG. 8 shows another embodiment of a specimen sample collection deviceand test system.

FIG. 9 shows another embodiment of a specimen sample collection deviceand test system.

FIG. 10. shows the interior layout of a specimen sample collectiondevice.

FIG. 11 shows an embodiment of an absorbent pad.

FIG. 12 shows another embodiment of an absorbent pad.

FIG. 13 shows another embodiment of a specimen sample collection deviceand test system.

DETAILED DESCRIPTION

Before beginning a detailed description of the subject invention,mention of the following is in order. When appropriate, like referencematerials and characters are used to designate identical, corresponding,or similar components in differing figure drawings. The figure drawingsassociated with this disclosure typically are not drawn with dimensionalaccuracy to scale, i.e., such drawings have been drafted with a focus onclarity of viewing and understanding rather than dimensional accuracy.

As shown in FIGS. 1, 4, a specimen sample collection device 10 includesa handle 14 with a sufficiency indicator, such as a light pipe indicatorwindow 18, and an absorbent pad, which can be a rounded tongue absorbentpad 15. As shown in FIG. 1, a specimen sample collection device and testsystem 12 includes a specimen sample collection device 10, a padcompression tube, which can be a dual outlet single channel compressiontube 20, and a collection tube, which can be a chambered collection tube26

Absorbent pad fits partially within the handle. As shown in FIGS. 1, 4,7, and 10 at 15, absorbent pad can be rounded to provide the advantageof comfort to the sample subject. As show in FIGS. 8 and 9 at 115, theabsorbent pad can be split, i.e., divided into two parts and connectedat the base of the pad to allow for dual sample collection. The splitabsorbent pad 115 can be prong- or fork-shaped or have splits of varyinglength. Those of skill in the art are aware that the absorbent pad canbe divided into more than two parts. In this embodiment the splitabsorbent pad 115 is configured such that one prong of the pad canabsorb at least 1.0 mL of specimen, and the other pad can absorb atleast 0.5 mL of specimen, when a highly absorbent pad material e.g.Ahlstrom 320 or Schleicher & Schuell 300 grades are chosen. When asplit, divided, prong or fork shaped absorbent pad is placed into thetest subject's mouth each split or division of said absorbent padabsorbs saliva at the same time, thus collecting identical salivasamples. One of skill in the art would also realize that the absorbentpad could be two or more separate and distinct absorbent pads. Absorbentpad can also be provided with a bifurcated-end in a smooth “m” shape onthe end of the pad interior of the handle to deliver saliva to the endsof two test strips simultaneously.

The absorbent pad soaks up specimen when placed in a specimenatmosphere, such as for example, soaking up saliva when placed in asubject's mouth, preferably under the tongue. Absorbent pad is notfilter paper. Filter paper is designed specifically to have porousopenings to have control or “filter” the size of material passingthrough it. The purpose of the absorbent pad is to collect and dispersea high volume of liquid sample yet remain relatively rigid through thesample collection procedure. Thus, an advantage is obtained by using anabsorbent pad rather than filter paper. Absorbent pad may be a varietyof different materials that will absorb liquid and release or transmitsaid liquid following an action carried out to facilitate removal ofsaid liquid from the pad.

Pad materials have a variety of properties, which may affect the abilityof a substance to adhere (or bind) to that specific absorbent padmaterial effectively, and also for that material to be suitably releasedfrom the pad when required. One particular property is a material'shydrophobic or hydrophilic characteristics. Hydrophilic materials arereadily “wet” with aqueous solutions and so aqueous based fluids, suchas saliva, urine, whole blood, vaginal fluid, etc. (containingantibodies, minerals, and other analytes of interest, will be readilyabsorbed by hydrophilic pad materials and released effectively. In thepreferred embodiment of this invention for example, absorbent padmaterial is made up of hydrophilic materials from a list includingAhlstrom materials catalog numbers 270 and 320, Schleicher & Schuellcatalog numbers 300 and 900 among others. Experimentation has shown thata large cross-section of substances to be detected or measured in fluidscan be carried out using one of these versatile products. Hydrophobicpad materials will not adequately “wet” in aqueous solutions but will bewetted in low surface tension liquids such as alcohols, hence the needfor the addition of low alcohol concentrations in any buffering systemused.

Those skilled in the art know that numerous materials meeting theserequirements exist, such as various cotton linters, for exampleSchleicher & Schuell (US) papers 300, 900, 903 or 2992, fiber compositematerials such as materials available from Ahlstrom (US) for instanceAhlstrom 270, a multi-purpose cellulose material that has been used forfluid collection and release and Ahlstrom grade 320 material, a materialwith hydrophobic characteristics. Also glass fiber, certain polymericmaterials, spunbound polyester materials (e.g. Hollytex brand fromAhlstrom, (US), extruded fibers, other cellulose papers manufacturedfrom raw material cellulose (e.g. Ahlstrom Paper group (US) and Filtrona(US) Transorb® materials), mixed fiber papers (e.g. Whatman (UK) PadsS9036-2009) as well as two-ply materials for example. The properties ofthese materials vary from absorbent materials with low protein bindingcapability to those with high binding capacity. Materials are availablein various thicknesses and sizes and may be easily customized to suitthe specific intended application for the pad material. Already, adiverse range of product materials is available form several sourcesincluding Schleicher & Schuell, Ahlstrom, Filtrona, Porex, Whatman andothers as described above. These materials are typically manufacturedunder strictly controlled conditions to ensure uniform composition andabsorption/release of fluids from the pad. Several of theafore-mentioned materials have been widely used as diagnostic andanalytical testing components and have been certified as suitable forthese purposes. Those skilled in the art know that absorbent padmaterials may also include hydrophilic or hydrophobic components bound,or integrated into the material, such components being capable ofmodifying the absorption and release characteristics of the absorbentpad as well as the speed of uptake of the sample fluid underconsideration. In the majority of cases antibodies minerals andsubstances will be readily removed from the absorbent pad upon squeezingthe pad in the compression tube according to the operationalinstructions supplied herein. However, in certain instances, materialsthat are difficult to remove e.g. hydrophobic materials includingprogesterone, testosterone, estradiol, other steroid hormones andΔ9-Tetrahydrocannabinol (THC), will be collected in a further embodimentusing a pad with hydrophobic properties. In this embodiment a smallpercentage of low molecular weight alcohol (ethanol, methanol orbutanol, for instance) at a concentration of 0.1%-4.0% is added.

The binding characteristics of various protein and other molecules tothe absorbent pad is another important factor. This particular propertyinfluences the nature of the binding of a given material to absorbentpad materials and is carefully considered when choosing products for agiven application. Materials with high-binding characteristics may insome instances be used to encourage removal of certain analytes from theoral cavity, which may be difficult to obtain using pad materials withlower binding characteristics. In these cases, release agents such asalcohols, Tween 20 and others may be used.

Other properties, which can impact the performance of absorbentmaterials and hence the ability to collect an optimum fluid specimeninclude thermal stability, pore size and pad size. The dimensions andmaterials used in the preferred embodiments of this invention includingAhlstrom 270 & 320, Schleicher & Schuell 300 & 900 cellulose materialsand others have been well characterized by the manufacturers and arealso available in published works.

To one skilled in the art there are also a spread of materials, whichoffer a choice of “wicking rate”, meaning the rate at which sample fluidis absorbed by the paper or pad material, so it is important foroptimization purposes to work with individual manufacturers of suchproducts to choose the optimum characteristics necessary to achieve thebest results.

To one skilled in the art it is further apparent that modification ofthe properties of the absorbent pad can be made by the addition ofvarious agents at the time of manufacturing the pad material. Thisinvention has been conceived as a means of providing a method forcustomization and optimization of the properties of pad materials for awide range of specific applications for which fluid collection isrequired. Further it is understood by one skilled in the art thatmodification of the dimensions of the pad (for instance thickness,width, height and others) can modify the absorption characteristics ofthe pad material. Materials such as those cited here are availablethrough a number of companies including Whatman (UK), Ahlstrom(Finland), Schleicher and Schuell (US), Porex and Filtrona (US), whichare chosen here by way of examples. While the above list of materials isconsiderable, these may or may not be suitable for the collection ofcertain types of specimens in fluids, for example steroid hormones, THCand certain other drug substances and others, for instance, which have atendency to “stick to” certain pad materials and can be bound tightly.An embodiment of this invention therefore, teaches a method of usingalternate pad materials in order to obtain the optimum system forcollection and subsequent testing or analysis of certain hormones, drugsand any materials likely to cause difficulty in analyte removal from thepad. The ability to provide flexible options for pad materials is anovel invention. An advantage of this is that the pad material may bemodified and optimized to suit the subsequent analysis, testing, orother action to be performed.

In an alternative embodiment, as shown in FIGS. 11, 12, absorbent padcan be a folded in half providing a double layer absorbent pad toprovide additional structure for the absorbent pad and increase thesurface area and absorption volume. FIG. 11 at 200 shows one possibleshape, with the pad folded upon itself along the fold line at 202, whichcan be used with the specimen sample collective device 10. FIG. 12 at204 shows a split absorbent pad shape, with the pad folded upon itselfalong the fold line at 206. Those skilled in the art will know thatabsorbent pads can be folded in a number of ways to reach the result ofproviding a double layer absorbent pad for additional structure and anincrease in the surface area and absorption volume.

As shown in FIGS. 2, 3, 4, sufficiency indicator is preferably a shapedlight pipe 18 with a color or indicator on one end 18 a, which is placedin contact with the absorbent pad 15. It is preferably made of styrolux.As show in FIGS. 2, 3, when the absorbent pad is saturated withsufficient sample, the reflectance of the pad changes causing a changein the refractive properties of the light pipe, seen as an altering ofthe color or indicator, which is seen as a line 18 b. The indicator iscapable of distinguishing and providing a visual indication between adry and wet absorbent pad. The absorbent pad is opaque when dry andprovides a good reflecting surface. However, when the absorbent padbecomes wet, the pad develops a surface film of liquid and also becometranslucent. This reduces the absorbent pad's reflective ability and theline 18 b is no longer visible to the user.

Alternatively, the sufficiency indicator can be a molded or otherwisemanufactured window, convex side downward, and frosted or textured suchthat when absorbent pad expands by absorption of sufficient sample, thewet absorbent pad touches the inside of the indicator resulting in achange in window clarity, clear spot or symbol indicating that adequatesample volume has been achieved. In this embodiment, an expandablematerial in contact with an absorbent pad, expands behind and obscuresan indicator providing a visual indication that sample volume isadequate when an adequate sample content is reached.

Alternatively, the sufficiency indicator can be a clear window with asmall absorbent pad with a colored dot on the inward side, attached onthe inside of the window. When the absorbent pad expands against theabsorbent paper, the liquid from that pad is transferred to theabsorbent paper. Becoming wet, the absorbent pad becomes translucentduring which time the colored dot becomes visible through the absorbentpaper and becomes visible in the sample adequacy indicator.

Alternatively, the sufficiency indicator can be coated on the insidewith a chemically neutral hydrochromic material such that when absorbentpad swells with sample it absorbs, the swollen pad touches the inside ofthe indicator, reacting with the coating and causing a color change orgraphic symbol to appear. Those skilled in the art know that manydifferent chemically neutral hydrochromic coating materials can be usedwhich would not alter the test samples.

Alternatively, the sufficiency indicator is a simple Liquid CrystalDisplay (LCD) device with two bi polar metal leads pressing into theabsorbent pad. When the pad is of adequate saturation, galvanic actioncauses a small electrical current. to flow between the metal leadscausing the LCD to darken.

Alternatively, the sufficiency indicator is configured as a snap-upindicator that includes a plastic spring 370 set into a sponge-likematerial 372. Sponge-like material 372 can be any material that whenmoistened loses structural rigidity and softens. When material 372 issoftened by sample, for instance saliva absorbed by absorbent pad 315,one part of the“spring” 370 disengages from the sponge 372 and snapsagainst viewing window 318 in handle 314 providing visual and auralindication that sample volume is adequate.

Fluids are removed from absorbent pads by squeezing sample from the padmaterial through compression tubes. Alternate methods of fluid removalmay be envisaged as necessary to facilitate removal of said liquid fromthe pad. Such techniques include vortexing, squeezing, centrifugationand treatment with an agent to promote removal of non-constituentcomponents of the pad material among others. Pushing the handle into thepad compression tube compresses the absorbent pad expelling specimenfrom absorbent pad into the pad compression tube. As shown in FIG. 7,pad compression tube 20 when inserted over absorbent pad 15 and on endof handle 14 is in fluid communication with absorbent pad 15.

Pad compression tube can have one or more channels and one or moreoutlets. FIG. 8 shows a dual outlet dual channel pad compression tube120 having two outlets 122 a, 122 b. FIG. 9 shows a single outlet singlechannel pad compression tube 150 with a single outlet 152. FIGS. 1, 5 a,5 b, 5 c, and 7 show a dual outlet single channel pad compression tube20 with two outlets 22 a, 22 b.

As seen in FIGS. 7, pad compression tube 20 fits over and around theabsorbent pad 15, which is partially contained within the handle 14 (seealso FIG. 10), and tube 20 goes over the end of the handle 14. As shownin the embodiment in FIG. 8, handle 114 can be provided with a ridgedlock 160 which fits in a depressed key 162 on a pad compression tube120. Pad is pushed into pad compression tube until “locked” into placefor safety preventing contamination and infectious transfer.

Pad compression tubes are is made of polypropylene or acrylic or othersuitable material. Pad compression tubes can be provided with a tubecap, see 24 in FIG. 1 made of polypropylene or other suitable material.

A dual outlet dual channel pad compression tube 120 fits around a splitabsorbent pad 115. Pushing the handle 114 into the dual outlet dualchannel pad compression tube 120 compresses the split absorbent pad 115,expelling specimen from split absorbent pad 115 into the dual outletdual channel pad compression tube 120. Dual outlet dual channel padcompression tube 120 when inserted over split absorbent pad 115 and onend of handle 114 is in fluid communication with split absorbent pad115. As shown in FIG. 8, the dual outlet dual channel pad compressiontube 120 includes a structural barrier 140 hat separates the two partsof the split absorbent pad 115, such that when the pad 115 is compressedupon entry into the compression tube 120, the saliva sample from eachsaid part of the pad 115 remains distinct and separate. Next, eachseparated saliva sample flows or is compressed into its ownEppendorf-style collection tube 126, which is attached to a compressiontube, see 120 in FIG. 8 and 150 in FIG. 9.

The pad compression tube outlets can also each contain a particulatefilter (not shown). Each distinct and separate saliva sample passesthrough its own particulate filter remaining distinct and separate.

The pad compression tube can contain a buffer solution to stabilize thesample obtained for analysis or testing. Suitable buffers include anaqueous solution with any of a variety of salts including sodiumchloride, sodium phosphate, ethylene diamine tetra acetic acid (EDTA)salts or others. Buffer solution may contain a preservative to maintainthe integrity of the sample and minimize degradation. This preservativeserves to inhibit proteolytic properties of enzyme materials that cancause destruction of the antibody molecules being tested with the deviceover time. The types of compounds that can be considered as conferringpreservative properties include enzyme inhibitors, anti-bacterialagents, bacteriostatic molecules, and anti-fungal compounds amongothers. Within the sub-group of bacteriostatic molecules, there are anumber which can be added to also inhibit the growth of microorganisms.Such compounds include ProClin® (in various formulations) sodium azideand thimerosal.

The buffer solution may also include a detergent material, whichimproves antibody removal from the absorbent pad material, when desired.Preferred examples of this are Tween-20 (chemical name polyoxyethylenesorbitan monooleate) and sodium dodecyl sulfate (SDS), although otherexamples, e.g. Triton X-100, chlorhexidine and others may also be used.Tween-20 for example, is also useful for prevention of non-specificbinding of required antibody molecules to unwanted solid surfaces.Typical concentrations of Tween-20, for instance, necessary to achievethe desired effect, range from 0.1%-1%. Similarly, low molecular weightalcohols (ethanol, methanol, butanol, etc.) in low concentrations(0.1-4.0%) can be introduced as additional analyte-releasing agents,depending upon the material under investigation.

Those skilled in the art will know that there are many possible agentscapable of being used as “buffering components”. Alternately the padcollection tube may contain no reagent or liquid whatsoever.Alternately, the pad collection tube may contain a non-fluid containingbuffer, i.e. a buffer without liquid, commonly referred to as a “drybuffer”. The permutation and concentrations of any agents used as partof the collection procedure will be optimized for the collection ofspecific target molecules. In the case of analytes or materials that aredifficult to release from the pad material under “normal” bufferconditions, for example “sticky” materials such as the drug THC, orsteroid hormones (including testosterone, estradiol, progesterone andothers), various reagents including small quantities (less than 5%) ofan alcohol, e.g. methanol, ethanol, propanol, iso-propanol may be addedto facilitate analyte release.

Typical buffers include phosphate buffered saline consisting of, forexample: 10 mmol/L Sodium Phosphate Dibasic; 150 mmol/L Sodium Chloride;5 mmol/L Disodium Ethylenediamine Tetraacetate (EDTA); 31 mmol/L SodiumAzide; Adjusted to neutral pH of 7.2

Collection tubes can be a chambered collection tube 26, as shown inFIGS. 1, 6 a, 6 b, and 6 c, or individual collection tubes 126, as shownin FIGS. 8 and 9.

Chambered collection tube 26 is shown in different views in FIGS. 6 a, 6b, 6 c. Ccollection tubes fit over the end of the pad compression tubeand have one or more more chambers for receiving and holding collectedsamples. These chambers or compartments are separated allowing samplesto remain distinct and free from contamination. In any embodiment,collection tube, at 26 in FIG. 1 and at 126 in FIGS. 8 and 9, wheninserted on end of pad compression tube, 20 in FIG. 1, 120 in FIG. 8,and 150 in FIG. 9 is in fluid communication with pad compression tube.Collection tube, at 26 in FIG. 1 and at 126 in FIGS. 8 and 9, can beprovided with a tube cap, at 28 in FIG. 1, and at 128 in FIGS. 8 and 9,sealing the tubes.

Eppendorf-type collection tubes 126, in FIGS. 8 and 9, collect theseparate and distinct saliva samples once they pass through a padcompression tube. Eppendorf-type collection tubes 126 are conical attheir closed end, round at the open end, and comprised of flexible lids128 that remain attached to the tube 126 whether open or closed. TheEppendorf-type collection tubes 126 may be attached together on theoutside surface. The Eppendorf-type collection tubes 126 remain inwardlydistinct in that each receives one of the distinct and separate salivasamples and said samples remain separate and distinct once in theEppendorf-type collection tubes 126. The Eppendorf-type collection tubelid 128 is then closed, retaining the fluid sample's integrity andquantity.

Handles, pad compression tubes, and collection tube can be made usingany number of different processes familiar to those with skill in theart, such as by injection molding, compression molding, casting;incorporating materials such as thermoplastics, thermosets, glass,metal, etc. The light pipe indicator window can be made of clearmaterial-glass, plastic, Perspex; sample sufficiency indicator changescolor or when something is moved, i.e., changes condition.

In the preferred embodiment, handle is made of two elongated pieces ofGeneral Purpose Styrene which fit together over a portion of theabsorbent pad. See FIG. 10. Handle is preferably made of two pin andultrasonically assembled halves. Those of skill in the art know that thehandle can be made of any one of numerous materials.

In the preferred embodiment collecting saliva, though other embodimentsfor collecting samples other than saliva exist (such as collection ofwater for environmental testing purposes, urine analysis for drugtesting, bioavailability testing in the pharmaceutical industry and manyothers), absorbent pad is placed in the mouth under the tongue.Absorbent pad expands when a specimen sample is received. When indicatorindicates sufficient sample has been obtained, Indicator provides avisual indication of the same.

In order to enrich the specimen with immunoglobulins, which are presentunder the lip line at the end of the collection process, the specimensample collection device is taken and “swabbed” once across the gumsfrom one side to the other, then reversed and swabbed across the gumline a second time in the opposite direction.

In order to collect saliva, the specimen sample collection device isplaced under the tongue and allowed to remain there until the visualindicator in the device-a light pipe showing a bluecoloration-disappears completely. The typical collection time for sampleadequacy is in the range of 1-2 minutes. The disappearance of the visualindicator may be observed by a second person or in the event of thesample being collected in the privacy of the home, by a donor inisolation The device may be removed from the mouth to visually inspectfor the disappearance of the color and replaced under the tongueimmediately without detriment to the collection or subsequent testprocedure.

In operation using a split absorbent pad 115 and a dual outlet dualchannel pad compression tube 120, the user places the pad 115 into thedual outlet pad compression tube 115 with the split end facingdownwards, and places the Eppendorf-type collection tube 126 on theoutlets 122 of the dual outlet pad compression tube 120, and pushes onhandle 114, forcing the pad 115 all the way down to the bottom of thecompression tube 120 until the end of the handle 114 can be pushed nocloser to the bottom of the compression tube 120. Pushing expelsspecimen from split absorbent pad 115, which then travels in fluidcommunication through the dual outlet pad compression tube 120, throughthe outlets 122 and into collection tubes 126. The collection tubes 126thus provide samples for supplemental or confirmatory testing as well asfor independent storage or transportation. Two samples are thusprovided. Depending upon the dimensions and type of pad material usedthe individual forks of the absorbent material will release between 0.3ml and 2 ml of pure saliva. In instances where the individual samples,are to be transported to a laboratory or remote location, or are not forimmediate testing, a preservative buffer may be introduced either in thecompression tube or the collection receptacles to maintain the integrityof the sample so collected. The buffer may be a liquid or dry buffer. Ininstances where the samples are to be tested immediately, or at thepoint-of-care, the device may be supplied without buffer. In order todetermine the volume of specimen received by this action, graduatedtubes, such as small Eppendorf tubes, available “off the shelf” from anumber of vendors, may be used. Alternatively, where no duplicatesampling is required, the collection tube can be a single channelcollection receptacle or Eppendorf tube. Depending upon samplingrequirements alternative customized collection tubes may be adapted foruse with the invention. Each of the tubes used in connection with thecollection tool are fitted with individual caps for sealing purposes.These caps may be tamper-proof for evidentiary purposes. Similarly, thepad compression tube can be provided with a cap or caps for sealing.

The specimen sample collection device 10 can be provided with one ormore lateral flow test strips 16 a, 16 b in the handle 14 in fluidcommunication with the absorbent pad 15 by one or more membranes 17 a,17 b. Such tests strips, for example ICT strips are commonly used in thediagnostic industry today, to screen for a plethora of diseasesincluding HIV, streptococcus A & B, hepatitis A, B & C, cardiac markers(e.g. troponin I, troponin T, myoglobin), tumor markers (e.g. prostatespecific antigen (PSA), alpha-fetoprotein (AFP), etc.), glucose,cholesterol and others.

The test strip is coated or “striped” with one or more analyte ofinterest, together with a control material usually Protein A-gold coatedto human IgG to verify that the test strip is working appropriately.Such strips are now very commonly available and well characterized.After a short period of time (which may vary from 2 to 20 minutes), aControl Line will appear on the test strip, and in instances of apositive specimen a second line (the Test Line) will appear indicatingpositivity for the analyte of interest.

The test strip is comprised of reagents that test qualitatively (for thepresence or absence of analytes or substances) and/orsemi-quantitatively (providing an estimate of the quantity) of thechemical(s)/substances for which the device tests within the fluidsample. In the preferred embodiment the test strip is located in thecollector handle housing, above the attachment loci of the absorbentpad. The collector handle housing has a window-type opening above aportion of the test strip through which results from the test strip canbe viewed.

A reagent test strip comprised of at least one reagent chemical thatupon contact with the chemical for which it tests or a by-product of thechemical for which it tests in the testing fluid, undergoes a chemicalreaction which produces or activates an indicator, preferably visual, ofthe presence or absence and/or quantity of the chemical for which ittests.

The test system may be applied to a number of different diseases, andanalytical tests, which includes HIV, drugs of abuse, bacteria, viruses,environmental toxins and others. Reaction times and run times will varydepending upon the characteristics of individual test strips, which areoptimized to achieved maximum sensitivity and specificity. Thecharacteristics of each individual test will be defined in therespective package insert for the products, however, as an example, anHIV test optimized for oral fluid detection using the specimen samplecollection device will provide results within a period of 10-20 minuteswith a sensitivity greater than 95% and a specificity of greater than99%. What should be understood in the case of an HIV test is that theappearance of a Test Line in the presence of a Control Line isindicative of an initially positive or non-negative result.

When more than one test strip is provided they are arranged side-by-sideon the handle 14, as shown in FIGS. 4 and 10, at 16 a, 16 b. In thisembodiment, saliva collected in identical fashion to the embodimentsdescribed above, is transferred to two test strips instead of one by twomembranes, 17 a, 17 b. Using this configuration, a multiplicity ofanalytes, for instance drugs of abuse, including but not limited to theNIDA-5 series of drugs, benzodiazepines, Oxycodone, and others, as wellas therapeutic drugs and multiple infectious diseases for instance maybe detected simultaneously using a single oral fluid collection deviceand test system. Test strips for the NIDA-5 series of drugs have beenoptimized in the specimen sample collection device to run within 15minutes from the time sample adequacy has been achieved.

In this embodiment, the reagent test strips 16 are located in thecollector handle 14 housing with a window-type opening 60 above eachtest strip 16, or, alternatively, a single window-type opening above allthe test strips. Each test strip contains a reagent test for analyzingthe qualitative (presence or absence) and/or quantitative data of thechemical for which it tests within the fluid sample. One of skill in theart would understand that each test strip may test for a differentchemical or the same chemical as any other test strip. In the preferredembodiment, the test strips extend linearly down the length of thecollector handle housing, parallel to one another. In anotherembodiment, the test strips may be adjacent to one, two or moreadditional test strips.

In embodiments including a test strip 16 under a test strip opening 60,the results may be read visually or may be read by electronic readingdevices including pocket-PC devices, PDAs and others. In the preferredembodiment of this invention a pocket-PC driven system, utilizesproprietary software to digitally record images from the lateral flowtest strips. The reader combines a “Pocket PC” (PDA-sized) readingsystem, printing device, camera and software, capable of readingmultiple lines within a pre-set reading window. Once the specimen samplecollection device incorporating one or more test strips has run and theimmunochromatographic test results have been observed visually, (afterthe pre-established reaction time is over), a plastic cap is placed overthe absorbent collection pad of the specimen sample collection device,if desired, then the opposite end of the device (handle-first) isinserted into the port of the hand-held reading device. The readingdevice initially does a diagnostic “self test” to ensure that the readeris working appropriately then performs a read out of the intensity ofthe coloration of the individual line (or lines) on the test strip (orstrips). The results of this are fed automatically to a printing device,which prints out a permanent record of the results for each drug orother analyte being tested. The visual appearance of a line, or theconfirmation of a line in the case of drug tests using the hand-heldreading system is an indication that the test is negative ornon-positive for that particular analyte or drug. This is the oppositeof what one would find for similar tests for HIV and other analyteswhere the presence of a Test Line in the presence of a Control Line isindicative of a positive or non-negative result. The invention providesvisually read, qualitative results, which may be quantitated usingavailable electronic, digital or other format readers. These in turn maybe either small, PDA-sized (hand-held) systems or portable and nonportable instruments that utilize electromagnetic radiation,chemiluminescence, digital photography and other techniques, whileproviding a digital printout of the quantitative results obtained.

Fluid forced through separate porous filters in pad compression tube andinto mutually distinct gradiated Eppendorf-type tubes attached to thepad compression tube outlets. Each Eppendorf tube is then bar coded. Abar code may further be provided on the specimen sample collectiondevice handle. A recess is molded into the specimen sample collectiondevice handle and the bar code is imprinted thereon.

Those skilled in the art will recognize that numerous modifications andchanges may be made to the preferred embodiment without departing fromthe scope of the claimed invention. It will, of course, be understoodthat modifications of the invention, in its various aspects, will beapparent to those skilled in the art, some being apparent only afterstudy, others being matters of routine mechanical, chemical andelectronic design. No single feature, function or property of thepreferred embodiment is essential. Other embodiments are possible, theirspecific designs depending upon the particular application. As such, thescope of the invention should not be limited by the particularembodiments herein described but should be defined only by the appendedclaims and equivalents thereof.

1. A specimen sample collection device, comprising: a handle having asufficiency indicator; and, an absorbent pad partially contained withinsaid handle; wherein said indicator includes a window, a sponge and aloaded spring set into said sponge, wherein said sponge is in fluidcommunication with the absorbent pad, such that when the sponge issoftened by absorption of liquid the spring partially or completelydisengages from sponge and snaps into view of said window, providingvisual and audible indication that sample volume is adequate.
 2. Aspecimen sample collection device and test system, comprising: a handlehaving a sufficiency indicator; an absorbent pad partially containedwithin said handle; a pad compression tube insertable over saidabsorbent pad within said handle and around an end of said handle, saidpad compression tube defining one or more pad compression tube chambers;and, a collection tube having one or more sample chambers, saidcollection tube attachable to said pad compression tube, and whereinwhen said collection tube is attached to said pad compression tube eachof said one or more chambers of said collection tube is in fluidcommunication with at least one of said one or more pad compression tubechambers, and further wherein said collection tube is detachable fromsaid pad compression tube and sealable; wherein said indicator includesa window, a sponge and a loaded spring set into said sponge, whereinsaid sponge is in fluid communication with the absorbent pad, such thatwhen the sponge is softened by absorption of liquid the spring partiallyor completely disengages from sponge and snaps into view of said window,providing visual and audible indication that sample volume is adequate.3. A specimen sample collection device, comprising: a handle having asufficiency indicator; and an absorbent pad partially contained withinsaid handle; wherein said absorbent pad is split, divided into two partsand connected at a base of said absorbent pad.
 4. A specimen samplecollection device and test system, comprising: a handle having asufficiency indicator; an absorbent pad partially contained within saidhandle; a pad compression tube insertable over said absorbent pad withinsaid handle and around an end of said handle, said pad compression tubedefining one or more pad compression tube chambers; and, a collectiontube having one or more sample chambers, said collection tube attachableto said pad compression tube, and wherein when said collection tube isattached to said pad compression tube each of said one or more chambersof said collection tube is in fluid communication with at least one ofsaid one or more pad compression tube chambers, and further wherein saidcollection tube is detachable from said pad compression tube andsealable; wherein said absorbent pad is split, divided into two partsand connected at a base of said absorbent pad.
 5. A specimen samplecollection device and test system as in claims 3 or 4 wherein saidsufficiency indicator comprises a light pipe having a first end surfacewith a marking; a second surface in physical contact with said absorbentpad creating a refractive boundary, wherein said second surface isoriented at an angle of incidence to said first surface such that whenthe absorbent pad absorbs a sufficient liquid sample the refractiveproperties of said boundary alter the observability of the mark.